Implantable pulse generators (IPGs) such as pacemakers and implantable cardioverter defibrillators (ICDs), which are used in the treatment of cardiac conditions, and neuromodulators or neurostimulators, which are used in chronic pain management or the actuation and control of other body systems, commonly include a housing, feedthrus, and a connector assembly that is enclosed in a header. Electrical stimulation originating in the housing is led to the connector assembly through feedthrus. The connector assembly serves to transmit electrical signals out of the IPG and to a lead electrically connected to the connector assembly, the lead transmitting electrical signals between the IPG and patient tissue.
Current header casting manufacturing processes and the associated methods of assembling the header and its enclosed connector assembly onto the housing require multiple operations, are skill intensive, and unavoidably time consuming. For example, at least some current cast-on header designs with quad pole (DF4/IS4) connectors require DF4/IS4 components to be stacked onto an inner core in an arbor press to form a DF4/IS4 assembly. Once the tip block is placed on the end of the inner core, the entire stack of components is compressed axially together along the inner core using the arbor press. With the stack of components so compressed, a set screw of the tip block is tightened down on the inner core to lock the stack of components in the compressed state, thereby forming the DF4/IS4 assembly. The DF4/IS4 assembly is then placed into a mold for casting headers and, once molded, the cast header is attached to the housing (e.g., can) of the pulse generator via additional skill intensive and time consuming processes.
Injection molded headers are considered to be a way of reducing manufacturing costs. In at least some versions of the injection molding of headers, the DF4/IS4 tip block must be overmolded into the header. Unfortunately, some of the DF4/IS4 components are not capable of withstanding the high pressures of injection molding (e.g., upwards of 20,000 psi), resulting in the components needing to be installed after the injection molded header is procured. Without the DF4/IS4 tip block, the stack of components can no longer be locked as a sub-assembly prior to installation into the header, thereby increasing manufacturing complexity, costs and time.
There is a need in the art for systems and methods that reduces the complexity, time, and costs associated with the manufacturing headers employing DF4/IS4 connectors.